Anthogyr 0459 Axiom Definitive Abutments User Manual

: October 31, 2023
: Anthogyr

Anthogyr 0459 Axiom Definitive Abutments

Instructions for Use

Aesthetic impacted abutments

| Aesthetic abutments| Straight standard abutments| Angulated standard abutments| Try-in abutments| Castable copings| Protection caps| Prosthetic screw for customized prosthesis
---|---|---|---|---|---|---|---

Axiom® 2.8

|

Axiom® BL

|

Axiom® BL Axiom® 2.8

|

Axiom® TL

| | | | | | |

Product description

The Axiom® definitive abutments range includes definitive abutments, try-in abutments, protection caps and castable copings.

These instructions for use are valid for the following

Axiom® components:
Aesthetic impacted abutments
Aesthetic abutments
Straight standard abutments
Angulated standard abutments
Try-in abutments
Protection caps
Castable copings
Prosthetic screw for customized prosthesis

A definitive prosthetic screw is supplied with Aesthetic abutments, Straight standard abutments and Angulated standard abutments, in the same packaging.

Materials:
Aesthetic impacted abutments, Aesthetic abutments, Straight standard abutments, Angulated standard abutments and screws are made of Titanium- 6Aluminium-4Vanadium ELI alloy:

Chemical components	Composition, % (mass/mass)
Aluminium	5.50 to 6.50
Vanadium	3.50 to 4.50
Iron	≤ 0.25
Oxygen	≤ 0.13
Carbon	≤ 0.08
Nitrogen	≤ 0.05
Hydrogen	≤ 0.012
Titanium	Balance

Protection caps are made of Polyetheretherketone (PEEK):

Chemical components	Composition, % (mass/mass)
Polyetheretherketone	100

Try-in abutments are made of Titanium (Ti6Al4V ELI). Castable copings are made of Polymethylmethacrylate (PMMA).

Intended use

Axiom® definitive abutments are intended to be placed into Axiom® dental implants to provide support for cemented restorations after oral implantation. Prosthetic screws for customized prosthesis are intended to be placed into Axiom® TL dental implants to provide support for screw retain customized restorations after oral implantation.
Try-in abutments are intended to be temporarily positioned in dental implants to represent the definitive abutment geometry after oral implantation.
Protection caps are intended to protect the coronary part of abutments during the healing phase after oral implantation.
Castable copings are intended to be cast in a metal part to produce a restoration adapted to the coronary parts of abutments after oral implantation

Indications

Aesthetic impacted abutments are indicated to support definitive single-unit cemented restorations on Axiom® 2.8 dental implants.
Aesthetic abutments are indicated to support definitive single-unit or multiple-unit cemented restorations on Axiom® BL dental implants.
Straight standard abutments are indicated to support definitive single-unit or multiple-unit cemented restorations on Axiom® BL dental implants.
Angulated standard abutments are indicated to support definitive multiple-unit cemented restorations on Axiom® BL dental implants.
Standard abutments can be used at the time of implant placement.
Prosthetic screws for customized prosthesis are indicated to support customized definitive single-unit screw retain restorations on Axiom L dental implants.
Protection caps are indicated to protect the coronary part of the abutment during healing process with abutment in place. Protection caps have a maximum duration of usage of 180 days.

Indication

Patient type and intended user

Aesthetic impacted abutments, Aesthetic abutments, Straight standard abutments, Angulated standard abutments, Protection caps, Castable coping, trying abutments and screws are intended for adults requiring a single-unit and/or multiple-unit tooth restoration and who do not present any of the conditions mentioned in the “Contraindications” section. These components must be placed by a surgeon trained in dental implantology.

Contraindications

Allergy or hypersensitivity to chemical components in the materials used and mentioned in the “Product description” section.

Warning

Implant surgery is a complex dental procedure. Incorrect techniques can cause implant failure and/or loss of bone support.
Appropriate training and qualification and a good knowledge of surgical techniques with Anthogyr products are required. Anthogyr offers specific training.

Caution/Precaution

Clinical use:

Single-use devices: do not reuse or re-sterilise.
Risk of contamination and risk of alteration of the functional surfaces.
It is important to perform a pre-clinical assessment and treatment plan that takes into account the anatomical constraints of the future restoration.
The definitive prosthetic component must be fixed on a sufficiently stable implant.
As far as possible, the prosthetic components must be firmly fastened to avoid the inhalation or swallowing of components during intraoral use.
The prosthetic components must not be tightened with a contra-angle.
Do not use a prosthetic part after the expiry date indicated on the packaging.

Component rework:

Aesthetic impacted abutments can be reworked only in the coronary portion in case where the impression is taken at the implant level.
Aesthetic abutments can be reworked only in the coronary portion.
Other components must not be reworked. The emergence profile must not be altered in order to maintain the original smooth surface.
Improper modification can induce mechanical weakening.

Safety information regarding magnetic resonance imaging (MRI):

The safety and compatibility of Anthogyr devices that
remain in the patient’s body have not been evaluated in the magnetic resonance (MR) environment.
They have not been tested for heat build-up, migration or artefacts in MR environments. The safety of Anthogyr devices in an MR environment is unknown.
Performing an MRI examination on a patient wearing such a device may result in injury.

Residuals risks and side effects

The clinical outcome of dental treatment is influenced by multiple factors.
The following residual risks and possible side effects are related to the use of Axiom® definitive abutments, Protection caps, Try-in abutments, Castable copings, Castable coping, trying abutments and screws and may lead to additional dental treatment at the dental practice:

Residual risks:

additional treatment at dentist’s office
bite/mastication/phonetic problems
bone damage
damage to adjacent/opposing tooth
discomfort
hyperplasia
hypersensitivity/allergic reaction
implant fracture
injuries of gingiva
irritation/inflammation
local or systemic infection (including peri-implantitis, periodontitis, gingivitis, fistula)
local pain
longer recovery/healing time than expected
loss of implant
loss of prosthetic component
poor aesthetic outcome
possibility of prolongation of surgery
possibility of surgical implant explanation
possibility to swallow/inhale small parts during the procedure
recall to the dentist’s office

Side effects:

swelling
local inflammation
bruising
resorption of maxillary/mandibular ridge bone
local infection
minor bleeding

Compatibility information

Anthogyr implants and prosthetic components are available in a wide variety of configurations. Only Anthogyr parts that are compatible with the implant connection are suitable for use. For more information, please refer to the manuals listed in the “Further information” section.

Cleaning and disinfection

Sterile components:

Anthogyr sterile prosthetic components are supplied sterile (GAMMA sterilisation) in blue packaging and are identified with a logo. They are intended for single use. Do not clean or sterilise the prosthetic components. Cleaning, disinfection and sterilisation can compromise the essential material and design features of the prosthetic components and result in device failure.

Non-sterile components:

Anthogyr non-sterile prosthetic components are supplied in white packaging and are identified with a logo. Before treatment, remove the components from their packaging. Do not use the components if the packaging is opened or damaged. They must be cleaned and decontaminated before use and after each use for reusable components. Anthogyr recommends following the protocol described in the “cleaning and sterilisation” manual available at ifu.anthogyr.com or on request from Anthogyr at the above address.
For sterilisation, see the “Sterilisation” section.

Sterilisation

Sterile components:

For sterile prosthetic components, check that the entire packaging of the device is undamaged before opening. Prosthetic components with a damaged packaging must not be used. It is recommended to have a replacement component readily available for use. The intact blister pack protects the sterilised prosthetic component against any external influence and, if stored properly, guarantees sterility until the expiry date. The blister pack must not be opened before use of the prosthetic component. When removing the prosthetic component from the sterile packaging, asepsis rules must be followed.
Anthogyr declines all responsibility for re-sterilised components, regardless of who carried out the re-sterilisation or the method used. Under no circumstances should a previously used or non-sterile prosthetic component be placed in the patient’s mouth.

Compatible information table

IMPLANT	ABUTMENT	SECONDARY PART	SCREW
Type of implant	Type of connection	Type of abutment
Compatible instrument	Compatible castable copping	**Compatible
protection cap**	Screw reference	Compatible instrument
Axiom® 2.8	Conical	Aesthetic impacted abutments	Prehensive wrench (OPOP028)
AND Impaction tip + SAFE LOCK®	OPPC028	OPCA028	–
Axiom® BL	Conical	Aesthetic abutments	Axiom® BL abutment gripper
(INEXPS/INEXPL)	–	–	OPTS160
Straight standard abutments	OPCA30X OPCA40X OPCA50X OPCA60X OPCR30X OPCR40X
OPCR50X OPCR60X	OPPC30X OPPC40X OPPC40X OPPC60X
Angulated standard abutments	OPCR30X OPCR40X OPCR50X OPCR60X
Axiom® TL	Indexed M1.6 connection (flat)	Simeda® customized abutment	–
–	TS160

If the original packaging is damaged, Anthogyr will not accept the return of the content.

Non-sterile components:

Anthogyr prosthetic components delivered non-sterile must be sterilised before use. Anthogyr recommends following the protocol described in the cleaning and sterilisation manual available at ifu.anthogyr.com or on request from Anthogyr at the above address.
After the sterilisation was done, asepsis rules must be followed.

Protocol for use

Refer to the brochures listed in the “Further information” section for detailed step-by-step instructions.
Axiom® 2.8

Step 1: Choose the right abutment

Clean and sterilise (See Cleaning and disinfection and Sterilisation) the try-in abutments.
Use the prehensive wrench for try-in abutment installation in mouth:
1. Insert the abutment in the wrench aligning the arrow marked on the wrench with the flat ledge of the abutment.
2. Place the abutment into the implant:
- To place the flat spot in the vestibular area, use the arrow to identify the flat spot.
- To place the flat spot in the lingual area, use the point (located at 180° of the arrow) to identify the flat spot (if not visible in the mouth).
1. Press the button on the wrench to release the abutment.
Place and remove different try-in abutments into the implant to find the most suitable one.
Choose the reference of the impacted abutment according to the try-in abutment selected.

Step 2: Place the aesthetic impacted abutment

Remove the abutment from the sterile packaging on the sterile field.
Before placing the abutment, ensure that the connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant.
Using the prehensive wrench, secure the abutment before transporting it in the patient mouth: follow the same steps as in “Step 1: Choose the right abutment”.
Before impaction of the definitive restoration in mouth, make a local anaesthesia if necessary.
Select the impaction tip which is adapted to the abutment:
In case of installation of a prosthesis cemented inside of the mouth, use one of the 2 adapted impaction tips, depending on the angulation of the abutment. For 15 and 23° angulated abutments, position the laser marking of the tip on the flat surface of the abutment.
In case of installation of a prosthesis cemented outside of the mouth, use the impaction tip adapted to the incisors to secure the prosthesis in the implant. For effective transmission of the impaction force, place the impaction tip firmly against the incisor edge of the prosthesis and as close to the implant axis as possible.
Position the flat ledge of the abutment in the vestibule (or in the lingual surface in the case of straight abutments) using the prehensive wrench.
Tighten the impaction tip on the SAFE LOCK®, adjust the motor speed to 10 000 rpm maximum. Position the tip on the abutment or the prosthesis before pressing the pedal and wait for 5 strokes.

Step 3: Protect the abutment during healing phase

Clean and sterilise (See Cleaning and disinfection and Sterilisation) the protection cap.
Clean the abutment ’s coronary part thoroughly.
Seal the protection cap onto the abutment using temporary cement.

Step 4: Place the crown onto the abutment

Use the castable coping as support for making the wax crown on the master model.
Make the metallic crown according to current casting and finishing protocols.
Remove the protection cap.
Cement the crown onto the abutment.

Axiom® BL
Choose the right abutment

Clean and sterilise (See Cleaning and disinfection and Sterilisation) the try-in abutments.
Secure the try-in abutments before transporting it in the patient mouth.
Place and remove different try-in abutments into the implant to find the most suitable one.
Choose the reference of the definitive abutment according to the try-in abutment selected.

A. Protocol for aesthetic abutments

Clean and sterilise (See Cleaning and disinfection and Sterilisation) the abutment and the definitive screw.
Before screwing the abutment, ensure that the connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant.
Place the abutment into the implant with Axiom® BL abutment gripper if needed.
Tighten the definitive screw to 25 N.cm with the hexagonal wrench and the prosthetic dynamometric wrench or with the hexagonal mandrel and the TORQ CONTROL®.
Close the screw channel.
Cement the restoration onto the abutment.

B. Protocol for straight and angulated standard abutments

Step B1: Place the standard abutment

Before screwing the abutment, ensure that the connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant.
Place the abutment into the implant with Axiom® BL abutment gripper if needed.
Tighten the definitive screw to 25 N.cm with the hexagonal wrench and the prosthetic dynamometric wrench or with the hexagonal mandrel and the TORQ CONTROL®.
Close the screw channel.

Step B2: Protect the standard abutment during healing phase

Clean and sterilise (See Cleaning and disinfection and Sterilisation) the protection cap.
Clean the abutment’s coronary part thoroughly.
Seal the protection cap onto the abutment’s coronary part using temporary cement.

Step B3: Place the restoration onto the standard abutment

Use the castable coping as support for making the wax restoration on the master model:
Use indexed castable coping for single-unit restoration.
Use non-indexed castable coping for multiple-unit restoration.
Make the metallic restoration according to current casting and finishing protocols.
Remove the protection cap.
Cement the restoration onto the abutment.

Axiom® TL

Clean and sterilise (See Cleaning and disinfection and Sterilisation) the prosthesis and the definitive screw.
Before screwing the prosthesis, ensure that the connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant.
Place the prosthesis into the implant.
Tighten the definitive screw to 25 N.cm with the hexagonal wrench and the prosthetic dynamometric wrench or with the hexagonal mandrel and the TORQ CONTROL®.
Close the screw channel.

Healing phase

The protection caps must be placed in sub-occlusion.

Lifespan of products

The Try-in abutments can be reused during 5 years, except in cases where there are signs of deterioration (illegibility of markings or markers, signs of corrosion, etc.).
Other components are for single-use.

Further information

For more information on the use of Anthogyr products, please contact your local Anthogyr sales representative or contact Anthogyr customer service or visit ifu.anthogyr.com and www.anthogyr.com.
For more specific information on the Axiom® definitive abutments, please refer to:

Axiom® 2.8 user guide (AXIOM2-8_NOT)
Axiom® Multi Level® Prosthetic user guide (AXIOM-MLP_NOT)

Subject to the availability of the European Medical
Device Database (EUDAMED), the summary of safety and clinical performance characteristics (SSCP) is available at https://ec.europa.eu/tools/eudamed.
Until EUDAMED is fully functional, the SSCP can be requested to Anthogyr at the following address:
clinical@anthogyr.com.

Product Type	Basic UDI-DI
Sterile Titanium abutment	36633940008QS
Non-sterile Titanium abutment	36633940009QU
Protective cap	36633940006QN
DLC coated prosthetic screw	36633940010QD

Storage

Store these products in a clean, dry area, at room temperature. Improper storage may compromise the essential characteristics of the materials and design, which may lead to device failure.

Waste treatment

Waste resulting from the intervention (packaging, part extracted, etc.) must be handled as medical waste under the responsibility of the user.

Patient information

Patients must accept regular medical follow-ups and should consult their doctor in the event of any unexpected change in the performance of the prosthetic reconstitution.
Patients must be informed of the need to ensure regular oral hygiene.
Patient must be advised to remain cautious for the first few weeks after surgery.
Traceability information is available to patients via the detachable labels on the device.

Notes

The practitioner must have the necessary knowledge to practice dental implantology and must be familiar with the handling instructions for Anthogyr products as described in this document in order to use Anthogyr products safely and in accordance with their instructions for use.
Anthogyr products must be used in accordance with the manufacturer’s instructions for use. The dental surgeon is solely responsible for the proper use of Anthogyr products in accordance with their instructions for use and to determine whether the product is suitable for the individual patient’s situation.
Anthogyr products are part of a complete range and must be used in combination with the corresponding original components and instruments distributed by Anthogyr, its parent company and any affiliates or subsidiaries of the parent company (“Straumann”).
The use of third-party products not distributed by Anthogyr voids any warranty or other obligation, express or implied, of Anthogyr.
Any product-related issues must be reported to the local Anthogyr organisation together with the product in question. In the event of a serious incident, the user must file a report with the local Anthogyr organisation and the appropriate competent authority in accordance with local regulations. Anthogyr also offers an online complaint service in the countries concerned.

Validity

The publication of this document supersedes and replaces all previous versions. Anthogyr all rights reserved.
Anthogyr® and/or other trademarks and logos of Anthogyr® mentioned herein are trademarks or registered trademarks of Anthogyr.

Availability

Some components of the Anthogyr implant system are unavailable in certain countries.

Symbols

The following table describes the symbols that may be printed on the packaging label. Please refer to the label on the packaging for the applicable product symbols.

Symbol	Description of symbol	Source of symbol
Manufacturer	NF EN ISO 15223-1
Date of manufacture	NF EN ISO 15223-1
Catalogue number	NF EN ISO 15223-1
Batch code	NF EN ISO 15223-1
Serial number	NF EN ISO 15223-1
Consult instructions for use or consult electronic instructions for use	NF